rules and guidelines 2013. adult sponsor qualified scientist designated supervisor institutional...
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Rules and Guidelines
2013
Adult Sponsor Qualified Scientist Designated Supervisor Institutional Review Board (IRB) Scientific Review Committee (SRC)
Oversees project to make sure that student◦ is informed of ISEF Rules and Guidelines◦ is aware of risks associated with project◦ is aware of forms required for project◦ will receive proper supervision during
experimentation◦ if required, submits project to IRB or SRC
Teacher usually serves as Adult Sponsor
Required for some projects Doctoral/professional degree related to
student researchor
Masters degree with SRC approval
Completes Form 2 – QS Form
Animal Care Supervisor for vertebrate animal projects
Supervises projects involving hazardous chemicals, activities or devices
Supervises projects requiring a Qualified Scientist when the Qualified Scientist cannot directly supervise the student
Reviews human participants studies Membership must include:
◦ an educator◦ a school administrator
someone knowledgeable about evaluating physical and/or psychological risk: MD, PA, RN, psychologist, licensed social worker or licensed clinical professional counselor
Reviews some projects before experimentation
Reviews all projects just prior to competition
Membership must include:◦a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., PharmD., D.O.)
◦an educator◦one other member
◦a biomedical scientist (Ph.D., M.D., D.V.M., D.D.S., PharmD., D.O.)
◦a school administrator◦an educator◦someone knowledgeable about
evaluating physical and/or psychological risk: MD, PA, RN, psychologist, licensed social worker or licensed clinical professional counselor
For all dates . . .NO cross outs, PLEASE.
A Research Plan is required for all projects. It must incorporate all of the relevant topics listed in the Research Plan Instructions.
Have students use this as a guide to write their plan. Reviewers look for information in this sequence.
Completed by me
Studies conducted at a research institution, industrial setting or any work site other than home, school or field require Form 1C
Project based on prior research in the same field of study
Longitudinal studies are permitted◦ Multi-year study◦ Studies time-based change
Require form 7
Human participants studies involve living individuals where there is
Intervention or interaction with participants
and/or Collection of identifiable private
information
Product testing of a student invention, program, concept, etc.◦No health hazards◦No personal data collected◦Feedback directly related to product
Studies using pre-existing, publicly available human data
Behavioral observations in unrestricted public settings◦ No interaction◦ No manipulation of environment◦ No recording of any personal identifiers
Studies using certified de-identified/ anonymous data
The IRB must review and approve the research plan before experimentation begins
Research participants 18 years of age or older must give informed consent
Research participants under 18 must give assent and their parents may be required to give permission
The IRB evaluates the project and determines◦Risk level◦Requirement for Qualified Scientist
◦Requirement for written informed consent/assent/parental permission
No more than minimal riskAnticipated harm and discomfort notgreater than encountered in daily life
More than minimal riskAnticipated harm or discomfort isgreater than encountered in daily life
More than minimal risk studies should require written consent/assent and parental permission. Final determination for this requirement made by the IRB
Physical risks◦ Exercise◦ Ingestion, tasting, smelling, application of
substances◦ Exposure to potentially hazardous material
Psychological risks Invasion of privacy Participant is a member of an at-risk
group
IRB decisions are documented on Form 4
Completed by SRC
If IRB determines that written informed consent/assent or parental permission is required, documentation is obtained on an “informed consent” document
Why do this? What purpose will the research serve?
Read the research plan guide and answer questions.
Live, nonhuman vertebrate mammalian embryos or fetuses
Bird and reptile eggs within 3 days of hatching
All other nonhuman vertebrates (including fish) at hatching or birth
Zebrafish embryos 7 days (168 hours) post fertilization
Induced toxicity studies involving known toxic substances that could impair health or destroy life
Behavioral experiments with◦ Conditioning using aversive stimuli◦ Mother/infant separation◦ Induced/learned helplessness
Studies of pain Predator/vertebrate prey experiments
Studies designed or anticipated to cause vertebrate animal death are prohibited.
Any deaths must be investigated by a qualified individual
If death was the result of experimental procedure the study must be terminated and the study will not qualify for competition.
There is no interaction with the animals
and There is no manipulation of the
environmentand
All federal or state fish, game and wildlife regulations are followed
School/Home/Field
Regulated Research Institution (must have an IACUC review and approval process)
◦ Universities◦ Government research agencies◦ Private research laboratories
Agricultural, behavioral, observational or supplemental nutritional studies
and Non-invasive and non-intrusive with
no negative effect on animal’s health or well-being
and Require SRC pre-review and approval
SRC determines level of supervision appropriate for the study:◦Designated supervisor◦Veterinarian◦Qualified scientist
Form 5A required
Please note
Must be approved by IACUC (Institutional Animal Care and Use Committee)
Local SRC should review project before experimentation
Experimentation must follow ISEF guidelines
QS completes Form 5B which includes documentation of IACUC approval
Microorganisms (including bacteria, viruses, fungi, etc.)
Recombinant DNA Human or animal fresh/frozen
tissues, blood or body fluids
Studies must have prior approval by SRC/IACUC/IBC
Most studies are prohibited in a home environment
Studies intended to genetically engineer bacteria with multiple antibiotic resistance are prohibited
Lab studies utilizing MRSA, VRE and KPC must be conducted in a Regulated Research Institution under documented IBC review and approval
Required of all PHBA projects Defines potential level of harm, injury
or disease to plants, animals or humans Involves
◦ Assignment of biological agent to risk group◦ Determination of level of biological
containment◦ Assessment of expertise of adult(s)◦ Assignment of final biosafety level
BSL 1 studies can usually be conducted in a high school or college teaching laboratory. See online checklist.
BSL 2 studies are usually conducted in a regulated research institution
BSL 3 and BSL 4 studies are prohibited for ISEF projects
Form 6A (Potentially Hazardous Biological Agents form) required for most projects involving microorganisms, and for all projects involving rDNA and fresh human and vertebrate animal tissues
Completed by SRC
Studies using baker’s and brewer’s yeast (except rDNA studies)
Studies using Lactobacillus, B. thurgensis, nitrogen-fixing bacteria, oil-eating bacteria, and algae-eating bacteria in natural environment. Not exempt if cultured in a petri dish environment
Studies of mold growth on food items if experiment terminated at first sign of mold
Studies involving protists, archae and similar microorganisms
Research using manure for composting, fuel production, or other non-culturing experiments
Studies using commercially available color change coliform water test kits
Studies involving decomposition of vertebrate organisms (forensic studies)
BSL 1 if◦ Organisms cultured in plastic petri dish◦ Culture dish remains sealed throughout
experiment◦ Culture dish disposed of in appropriate manner
BSL 2 if petri dish is opened
Experiments with BSL 1 organisms can be done in BSL 1 lab with a QS or trained DS
Experiments with BSL 2 organisms must be done in a regulated research institution with a QS
If animal is euthanized solely for student project – vertebrate animal study which requires IACUC approval
If animal is euthanized for a purpose other than student project – tissue study
Classification as BSL 1 or 2 based on source of tissue and possibility of containing infectious agents
All studies with human or wild animal blood are BSL 2. Studies with domestic animal blood are BSL 1.
Studies with human body fluids which can be associated with a person must have IRB approval
◦ Plant tissues◦ Plant and non-primate established cell and
tissue cultures◦ Fresh or frozen meat, meat by-products,
pasteurized milk, eggs – from grocery stores, restaurants, packing houses
◦ Hair◦ Sterilized teeth◦ Fossilized tissue/archeological specimens ◦ Prepared fixed tissue slides
Required for all projects using ◦Fresh/frozen tissue◦Primary cell cultures◦Human and other primate
established cell lines and tissue cultures
◦Blood and blood products◦Body fluids
Chemicals Equipment DEA-Controlled Substances Prescription Drugs Alcohol and Tobacco Firearms and Explosives Radiation
Studies do not require prior SRC review and approval
All studies require a Risk Assessment documented on Form 3
DEA - controlled substances require a Qualified Scientist
All other studies require a Designated Supervisor
DEA-Controlled Substances◦ Consult DEA list of controlled substances◦ All studies require Qualified Scientist◦ Controlled substances on Schedule 1 require
DEA protocol review
Firearms and Explosives◦ Must adhere to local training and
certification requirements ◦ Work in a contained area
◦ Must follow local laws for purchase, possession and consumption
◦ Home production of ethyl alcohol (wine or beer) must follow U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) regulations
◦ Alcohol distillation for fuel production can be conducted at school with TTB permit obtained by school officials
Prescription Drugs◦ Cannot be administered to human subjects◦ Animal administration must follow ISEF
vertebrate animal guidelines
Hazardous Chemicals◦ Refer to MSDS Sheets for safety and
handling guidelines
Hazardous Devices◦ Involve level of risk beyond that encountered
in student’s everyday life
Radiation◦ Non-ionizing◦ Ionizing
Required for all projects involving◦DEA-Controlled Substances◦Prescription Drugs◦Alcohol and Tobacco◦Hazardous Chemicals◦Hazardous Devices◦Hazardous Activities◦Radiation